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Materials Science - LGC Group · Materials Science Physical properties and solid form...

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Drug Development Solutions Materials Science Physical properties and solid form characterisation It is an essential requirement of the product development process in the pharmaceutical and consumer healthcare sectors to have a thorough understanding of the key physical and chemical characteristics of solid materials. A material’s physical properties and solid form will determine how it behaves in terms of, for example, its processability, flowability, compaction, strength, dissolution, compatibility and stability. We are highly experienced in the measurement of these properties on a wide range of materials including active ingredients, excipients and formulated products. Our expertise covers all stages of development, registration and manufacturing. Our key materials science services include: Physical Properties Testing Particle Size Distribution Particle Shape Analysis Specific Surface Area Scanning Electron Microscopy with elemental analysis using EDX Inverse Gas Chromatography – Surface Energy Analysis Dynamic Vapour Sorption (DVS) Density Porosity Optical microscopy Thermal microscopy Solid Form Characterisation Powder X-ray diffraction Thermal analysis (DSC and TGA) FT-IR (spectroscopy and microscopy) Assessment of amorphous / crystalline form Determination of hydrates, solvates and co-crystals Crystal structure solution and solid form risk assessment We have extensive experience working with a wide range of product formulation types including tablets, capsules, powders, ointments, creams, gels, coatings, adhesives, fibres and pastes. We support routine measurements, advanced characterisation and troubleshooting, bespoke method development and validation for all stages of the product development and manufacturing pipeline, from our GMP laboratories.
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Page 1: Materials Science - LGC Group · Materials Science Physical properties and solid form characterisation It is an essential requirement of the product development process in the pharmaceutical

Drug Development Solutions

Materials Science

Physical properties and solid form characterisationIt is an essential requirement of the product development process in the pharmaceutical and consumer healthcare sectors to have a thorough understanding of the key physical and chemical characteristics of solid materials.

A material’s physical properties and solid form will determine how it behaves in terms of, for example, its processability, flowability, compaction, strength, dissolution, compatibility and stability. We are highly experienced in the measurement of these properties on a wide range of materials including active ingredients, excipients and formulated products. Our expertise covers all stages of development, registration and manufacturing.

Our key materials science services include:

Physical Properties Testing

• Particle Size Distribution • Particle Shape Analysis• Specific Surface Area• Scanning Electron Microscopy with elemental analysis

using EDX• Inverse Gas Chromatography – Surface Energy Analysis• Dynamic Vapour Sorption (DVS)• Density• Porosity• Optical microscopy• Thermal microscopy

Solid Form Characterisation

• Powder X-ray diffraction• Thermal analysis (DSC and TGA)• FT-IR (spectroscopy and microscopy)• Assessment of amorphous / crystalline form• Determination of hydrates, solvates and co-crystals• Crystal structure solution and solid form risk assessment

We have extensive experience working with a wide range of product formulation types including tablets, capsules, powders, ointments, creams, gels, coatings, adhesives, fibres and pastes. We support routine measurements, advanced characterisation and troubleshooting, bespoke method development and validation for all stages of the product development and manufacturing pipeline, from our GMP laboratories.

Page 2: Materials Science - LGC Group · Materials Science Physical properties and solid form characterisation It is an essential requirement of the product development process in the pharmaceutical

Science for a safer world

lgcgroup.com/ddsRegistered OfficeLGC, Queens Road, Teddington,Middlesex, TW11 0LY

No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying,recording or any retrieval system, without the written permission of the copyright holder. LGC Limited, 2018. All rights reserved. HSI/0146/CS/1018

Our comprehensive service addresses challenges associated with:

• Bulk powder handling and processing• Solid form issues such as polymorphism, solvates,

salts and co-crystals• Chemical and physical stability• Dissolution, crystallisation and segregation• Compatibility between ingredients and packaging• Polymer deformulation and glass delamination• Pilot plant and commercial scale manufacturing

• Supplier change and raw materials evaluation studies

• Foreign particulates and contaminant identification• Root cause analysis of product failures• IP, patent litigation and counterfeits testing• Due diligence activities for in-licensed compounds• Raw materials testing• Analytical method transfer exercises.

Our team of industry experts operate to the highest quality standards of Good Manufacturing Practice (GMP), Our laboratories are certified for both chemical and physical testing by the Medicines and Healthcare Products Regulatory Agency (MHRA) and have also been successfully audited by the US FDA.

For further information on our materials science services, please contact us:

lgcgroup.com/enquiries

+44(0)1638 720500

Aerial photo of LGC’s Fordham, UK site

@lgc_dds @lgcgroup

@LGCDrugDevelopmentSolutions


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